Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-08-10FDA-DrugTeva North AmericaClass IIIChildren's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
- 2016-08-10FDA-DrugLet's Talk Health, Inc.Class IIOxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
- 2016-08-03FDA-DrugTeva North AmericaClass IIImitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
- 2016-08-03FDA-DrugSagent Pharmaceuticals IncClass IIOxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
- 2016-08-03FDA-DrugTeva North AmericaClass IIIDivalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
Failed Tablet/Capsule Specifications
- 2016-08-03FDA-DrugActavis IncClass IIDextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09
Failed Dissolution Specifications
- 2016-08-03FDA-DrugMedicap PharmacyClass IIAcetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
- 2016-07-27FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIbuPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Failed Dissolution Specifications
- 2016-07-27FDA-DrugGlaxoSmithKline, LLCClass IIBactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
Penicillin Cross Contamination
- 2016-07-27FDA-DrugGlaxoSmithKline, LLCClass IIBactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.
Penicillin Cross Contamination
- 2016-07-27FDA-DrugGlaxoSmithKline, LLCClass IIBactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,
Penicillin Cross Contamination
- 2016-07-27FDA-DrugGlaxoSmithKline, LLCClass IIBactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,
Penicillin Cross Contamination
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intrav
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-214-48
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- 2016-07-27FDA-DrugPharmedium Services, LLCClass II3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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